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AIM-V Medium

Oxford Immunotec, Inc. · Model AV.200/500 · UDI-DI 05051716000155

KZI
10
510(k) clearances
3,147
Adverse events
2
Recalls
17
Facilities

Description

AIM-V® serum free cell culture medium is intended for use in the preparation of peripheral blood mononuclear cells (PBMCs) from whole blood and for use as a culture medium for in vitro testing using the ELISPOT method. PBMCs, separated from whole blood samples, are washed with AIM-V medium and the cell pellet is re-suspended in the medium. The cells are counted using a haemocytometer or automated cell counter before being diluted to the required concentration in AIM-V.

Recalls

DateFirmReason
2009-02-19Becton Dickinson & Co.In vitro diagnostic test reagent may contain residual material that inhibits the growth of gram positive/gram negative organisms.
2004-09-27Remel, Inc.The product does not perform as intended with some quality control organisms (Haemophilus influenzae)

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.